BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3192249 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07385
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BATTERIES, CHARGER BOARD, AND THE FILAMENT DRIVE BOARD WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING BYPASSABLE CHARGER FAIL ERROR MESSAGES. HOWEVER, UPON FURTHER EVALUATION OF THE SYSTEM, THE FE EXPERIENCED FATAL CHARGER ERRORS AND A COMPLETE LOSS OF FLUOROSCOPIC ABILITY. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281535 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1